Patient Engagement

CTTI Unveils New Recommendations for Incorporating Patient and Site Perspectives in Mobile Trials

Posted on by Lorri Bingham

CTTI released new recommendations and resources today for engaging patients and sites when planning clinical trials using mobile technologies. These recommendations have the potential to help sponsors, CROs, and other stakeholders gain the full benefits of using mobile technologies in clinical trials, including remote participation, increased protocol adherence, and participation by a more diverse population.

While buy-in from stakeholders is critical to the success of mobile trials, little was known about patient and site perspectives until CTTI conducted surveys and interviews with patients and investigative site personnel to assess perceived benefits and barriers.

Engaging Patients and Sites Recommendations

The resulting recommendations have the potential to help research sponsors:

  • Engage patients and sites in protocol design, technology selection, and pilot testing
  • Maximize value and minimize burden for study participants by setting patient expectations, protecting privacy, returning data, enhancing patient-site interactions, and providing technical support
  • Address challenges for investigative sites, from contracting and budgeting to evaluating site readiness and implementing effective and streamlined training

“CTTI’s recommendations and resources are designed to take our understanding of patient and site needs in mobile clinical trials to the next level,” said Bill Wood, associate professor at the School of Medicine at the University of North Carolina at Chapel Hill. “With these new insights, sponsors and researchers can plan and conduct mobile trials that work better for everyone involved, streamlining the clinical research process and accelerating the development of critical new therapies.”

The recommendations are the fourth set generated through CTTI’s Mobile Clinical Trials (MCT) Program, following recommendations on developing novel endpoints generated by mobile technologies, using mobile technologies for data capture in clinical trials, and planning and conducting decentralized clinical trials. Additionally, they build on previous CTTI work—including our Quality by Design and Patients Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design.

CTTI and FDA Workshop Will Explore How Best to Include Patient Perspectives in Clinical Trials

Posted on by Lorri Bingham

CTTI will convene a public workshop, “Enhancing the Incorporation of Patient Perspectives in Clinical Trials” in collaboration with the FDA on Mon., March 18, from 9:00 a.m. to 5:00 p.m. at the Tommy Douglas Conference Center in Silver Spring, Md.

 

The workshop will seek ideas for best practices and key considerations for enhancing the incorporation of patient perspectives on clinical trial access, design, conduct, and post-trial follow-up. It will also gather input from patients, caregivers, industry, academic researchers, and expert practitioners on the challenges and barriers to patient participation in clinical trials. CTTI and the FDA are especially interested in the perspectives of patients, caregivers, researchers, and others who have participated in clinical trials and are willing to share their experiences.

 

This workshop meets an FDA commitment that is part of the sixth authorization of the Prescription Drug User Fee Act (PDUFA VI). After the event, a published report on proceedings and recommendations from the workshop will be made publicly available.

 

Register for the workshop by March 11. Registration is free and based on space availability, with priority given to early registrants. If you are unable to attend the workshop in person, you can watch the live webcast.

 

Don’t miss this opportunity to make your voice heard and shape the future of clinical research!

CTTI to Launch Recommendations for Engaging Patient and Site Perspectives in Mobile Clinical Trials

Posted on by Lorri Bingham

CTTI will host a public webinar on Thurs., Feb. 21, to announce new recommendations and resources for incorporating patient and site perspectives when planning and conducting mobile clinical trials.

“Acceptance and adoption by key stakeholders is critical to the widespread use of mobile technologies in clinical trials,” said CTTI Executive Director Pamela Tenaerts. “However, very little was known about patient and sites’ perspectives until our work shed light on what they see as significant benefits and barriers. Our new recommendations account for these perspectives and provide a valuable resource for optimally deploying mobile clinical trials.

“Further, they build on previous CTTI work—including our Quality by Design and Patient Groups and Clinical Trials recommendations—that emphasizes the involvement of many stakeholders, including patients and sites, in trial design. Engaging these groups early and often is the key to running better trials.”

CTTI conducted surveys and in-depth interviews to better understand the perceptions of patients and clinical investigators, and convened experts and leaders across the clinical trials enterprise to develop actionable recommendations and resources.

The resulting recommendations are designed to assist research sponsors in:

  • Engaging patient and site perspectives in planning clinical trials using mobile technologies, including protocol design, technology selection, and pilot testing
  • Maximizing value and minimizing burden for study participants, including setting patient expectations, protecting privacy, returning individual data, enhancing patient-site interactions, and providing technical support
  • Addressing challenges for investigative sites, from contracting and budgeting to evaluating site readiness and implementing effective and streamlined training

This is the final of four sets of recommendations CTTI has released as part of its Mobile Clinical Trials (MCT) Program. In 2017, CTTI announced recommendations for developing novel endpoints generated by mobile technologies and, in 2018, it unveiled new solutions for using mobile technologies for data capture in clinical trials, and recommendations for planning and conducting decentralized clinical trials.

The free webinar will begin at noon ET and will be led by patient advocate Cindy Geoghegan and Virginia Nido of Genentech, a member of the Roche Group.

Now Available: Summary of the Patient Engagement Collaborative Inaugural Meeting

Posted on by Lorri Bingham

The FDA, in collaboration with CTTI, convened the inaugural meeting of the newly formed Patient Engagement Collaborative (PEC) in August at the FDA’s White Oak Campus in Silver Spring, Md. A summary of the meeting is now available.

 

The PEC is a joint initiative of the FDA and CTTI. Its 16 members, selected from nearly 200 patients and advocates, are helping expand the FDA’s efforts to achieve meaningful patient engagement in medical product development and other regulatory discussions. This effort is facilitated by provisions in the 21st Century Cures Act of 2016 and the Food and Drug Administration Reauthorization Act of 2017.

 

The objectives of the PEC’s first meeting were to agree on the group’s vision and goals and to discuss opportunities to enhance communications and resources for interactions between the FDA and the patient community. Among the meeting’s key takeaways, the PEC agreed that patient engagement can inform the research and development continuum from beginning to end, and that a systematic approach by the FDA to including the patient voice in the regulatory decision-making process will be important.

 

The PEC will meet several times a year, both in-person and by teleconference, to continue to discuss how to enhance patient engagement in regulatory decision-making.

 

Sixteen Representatives Selected for the Patient Engagement Collaborative at FDA

Posted on by Lorri Bingham

CTTI and the FDA recently announced newly selected representatives for the Patient Engagement Collaborative (PEC), a joint endeavor announced in December 2017 to gather members of the patient community to discuss new ways for patients and the FDA to work together. These 16 representatives will meet with the FDA several times a year to discuss topics such as communication, transparency, and how patients can participate in the FDA’s regulatory discussions about medical products.

The representatives are:

  • Dawn Aldrich
  • Ronald Bartek
  • Karen Erickson
  • Jeffrey Goldstein
  • Anne Hall
  • Melissa Hogan
  • Elizabeth Joniak-Grant
  • Nancy Lenfestey
  • Isabelle Lousada
  • Stephanie Monroe
  • Lawrence “Rick” Phillips
  • Philip Posner
  • Lynne Quittell
  • Adrienne Shapiro
  • Theresa Strong
  • Dave White

The representatives were selected from nearly 200 nominations received in response to a Federal Register notice published in December 2017. The selection committee, which included patient advocates and staff from CTTI and the FDA, worked to identify representatives with diverse perspectives and experiences who could meaningfully contribute and express the patient voice.

“We are excited to welcome these experts to the PEC and are confident that they will make a significant contribution to advancing patient engagement in research and development,” said Pamela Tenaerts, MD, MBA, CTTI Executive Director. “This group will play a critical role in ensuring that every step of medical product development accounts for patients’ needs.”

The PEC was created as a response to public feedback the FDA requested on Section 1137, Patient Participation in Medical Product Discussions, of the Food and Drug Administration Safety and Innovation Act (FDASIA). One suggestion was to create an outside group to give input on patient engagement across the FDA.

CTTI Shares Latest Findings on Mobile Technology, Patient Engagement, and More at DIA 2018

Posted on by Lorri Bingham

At this year’s DIA 2018 Global Annual Meeting, CTTI will share insights across a broad range of topics that are core to its mission of enhancing the quality and efficiency of clinical trials. During the event, which will take place in Boston from June 24-28, CTTI will take part in 10 different presentations and sessions in areas ranging from patient-focused medical development to the use of mobile technology for data capture to quality approaches to clinical trial design.

 

Please join us at the CTTI exhibitor booth (#1624) and attend our presentations:

 

Presentation: The Metamorphasis of Clinical Trials: Evolving Roles of Stakeholders in Digital Trials
Date & Time: Mon., June 25, 11:00 a.m. – 12:00 p.m.
Presenters:  Angela Botto-van Bemden (Arthritis Foundation)
Related CTTI Project: MCT Stakeholder Perceptions

 

Presentation: Patient-Focused Medicines Development: Where It Has Led Us Today, What Challenges Remain and What Do We Still Need to Do to Achieve Success?
Date & Time: Mon., June 25, 11:00 a.m. – 12:15 p.m.
Presenter: Pamela Tenaerts (CTTI)

Related CTTI Projects: Patient Groups & Clinical Trials

 

Presentation: The Who, What, How, When, and Why of Using Mobile Technology in Clinical Trials
Date & Time: Mon., June 25, 11:00 a.m. – 12:15 p.m.

Chair: Robert DiCicco (TransCelerate Biopharma)
Presenters:  Philip Coran (Medidata Solutions), Cindy Geoghegan (Individual Patient/Caregiver), and Jan Hewett (FDA/CDER)
Related CTTI Project: MCT Mobile Technologies

 

Engage & Exchange Session: New Approaches, Novel Endpoints, and Next-Generation Trials
Date & Time: Mon., June 25, 1:45 – 2:45 p.m.

Chair: Jennifer Goldsack (CTTI)
Facilitators: Jessie Bakker (Philips Respironics), Daniel Karlin (Pfizer), and Komathi Stem (monARC Bionetworks)

Related CTTI Project: MCT Novel Endpoints

 

Presentation: A Quality-by-Design Approach to Trial Design and Conduct: Case Studies from the Clinical Trials Transformation Initiative
Date & Time: Mon., June 25, 3:00 – 4:15 p.m.

Chair: Annemarie Forrest (CTTI)
Presenters: Sabrina Comic-Savic (The Medicines Company) and Julie Dietrich (Amgen)
Related CTTI Project: Quality by Design

 

Content Hub: Developing Standards to Support the Use of Wearables and Sensors for Objective Data Collection During Clinical Trials
Date & Time: Tues., June 26, 1:30 – 2:00 p.m.
Presenter: Jennifer Goldsack (CTTI)
Related CTTI Project: MCT Mobile Technologies

 

Presentation: Debunking Decentralized Trials: Sharing Breakthroughs and Deal Breakers

Date & Time: Tues., June 26, 4:15 – 5:30 p.m.

Chair: Jane Myles (Genentech – a member of the Roche group)
Presenters: Gerrit Hamre (CTTI), Leonard Sacks (FDA/CDER), and Komathi Stem (monARC Bionetworks)
Related CTTI Project:  MCT Mobile Technologies, MCT Novel Endpoints

 

Presentation: Building up Efficiencies, Breaking Down Barriers: Using Mobile Technology for Data Capture in Clinical Trials

Date & Time: Tues., June 26, 4:15 – 5:30 p.m.
Presenters: Sunil Agarwal (HCL America) and James Streeter (Oracle)
Related CTTI Project: MCT Data Collection

 

Presentation: Redefining the Site Investigator’s Experience

Date & Time: Tues., June 26, 4:15 – 5:30 p.m.
Presenters: Kaitlin Malone (Amgen)

Related CTTI Project: Investigator Community

 

Presentation: Data and Quality Approaches to Informing Global Investigative Site Selection

Date & Time: Wed., June 27, 8:00 – 9:15 a.m.

Chair: Stella Stergiopoulos (Tufts Center for the Study of Drug Development)
Presenter: James Kremidas (ACRP)
Related CTTI Project: Investigator Qualification

 

Poster: Effective Engagement Between Sponsors & Patient Groups: A Structured Process and Use Cases from CTTI

Date & Time: Wed., June 27, 9:30 – 10:30 a.m., 12:00 – 2:00 p.m., 3:00 – 4:00 p.m.

Presenter: Zach Hallinan (CTTI)

Related CTTI Project: Patient Groups & Clinical Trials

CTTI Hosts Free Webinar to Highlight Key Initiatives of MDIC to Advance Medical Device Regulatory Science

Posted on by Lorri Bingham

CTTI will host a free, public webinar on Thurs., May 17, at 12:00 p.m. EDT to highlight key initiatives of the Medical Device Innovation Consortium (MDIC), a public-private partnership working to advance medical device regulatory science. Attendees will learn how MDIC’s and CTTI’s efforts—particularly around engaging patients as equal partners and driving single IRB adoption—complement each other to improve clinical trials.

 

Add to Calendar

 

Stephanie Christopher and Dan Schwartz of MDIC will present on topics including:

 

  • The Science of Patient Input initiative to develop a framework for patient input in clinical trials.
  • A preview of results from the project to integrate patient preferences into the design of clinical trials.
  • Early Feasibility initiative to highlight Early Feasibility Study (EFS) Metrics and Contract projects.

CTTI has long recognized that overcoming the complex challenges facing the clinical trials enterprise requires strong coordination across initiatives. By ensuring our enterprise-wide efforts are complementary and not duplicative, we can more efficiently and successfully improve the R&D process and increase the quality and efficiency of clinical trials.

 

Topic: MDIC and CTTI: Synergies in Clinical Trials Efforts

Date: Thurs., May 17, 2018, 12:00-1:00 p.m. EDT (GMT -04:00)

Presenters: Stephanie Christopher and Dan Schwartz (MDIC)